One of my favourite clients in Cork has just opened some really interesting 2 year contract roles in Manufacturing and Project Engineering. Driven by expansion they need a number of committed and ambitious Engineers to help them role out advanced in their manufacturing lines and processes.
If you have 5+ years in a Medical Device environment and experience of either the introduction of new Automated Manufacturing Lines or alternatively Product/Process Validations then give me a call on 087 3618142 or message me here for more.

About the Job:

• Initiate, co-ordinate and complete assigned projects within the engineering department within budget.
• Complete Process / Product / Equipment Validations in conjunction with Quality/Validation group.
• Conduct process feasibility trials / process DOE’s to determine appropriate/robust process windows.
• Prepare & execute OQ / PQ protocols for process / material changes as needed.
• Work in conjunction with the Quality & Validation group to determine appropriate validation sampling and acceptance criteria.
• Liaise with operations and technician group to prepare plan for validation builds.
• Co-ordinate the execution of OQ / PQ builds.
• Prepare OQ / PQ validation reports and deviations as required.
• Conduct process capability analysis using Minitab.
• Maintain and develop manufacturing process documentation and procedures. All process changes and modifications to be documented and tracked closely.
• Responsible for dealing with process, product and quality issues to achieve long term solutions.
• Lead and co-ordinate cost resolution projects year on year as per individual goals.
• Lead and co-ordinate Risk Mitigation initiatives such as FMEA and Risk Assessments.

Working Knowledge of the following would be an advantage but not a requirement;

• Automated / Semi Automated assembly equipment.
• Injection moulding and mould tools.
• High precision Punch & Die Sets.
• Heat sealing, ultrasonic welding, leak testing, vision systems.
• OEE Line performance methodology.
• Minitab/ Lean 6 Sigma techniques
• Root Cause Analysis methodology
• Microsoft Excel to an advanced level
• AutoCAD.

About You:

• Degree in Mechanical / Production Engineering or equivalent.
• Minimum of 3 years relevant experience, preferably within Medical Device industry or other regulated environments.
• Working knowledge of Product & Process validations essential.
• Excellent Engineering ability
• Strong organisational ability
• Self motivation and drive
• Demonstrate a high level of responsiveness to internal customers (eg. production)
• Communication- strong written, oral and presentational skills.

For more on the role call Nigel on 087 3618142 or send your CV for consideration.

Summary:
Our client is a global biopharma company based in Carlow and is looking for a Process Engineer who will provide technical support for commercial manufacturing and new product introduction. The right candidate will perform product risk management and quality risk management and will Design/ Author/ Review/ Approve/ Execute process development studies in support of new product introduction and ongoing manufacturing support and qualification/validation documentation and studies in line with the standard approval process.

Responsibilities:

• Serve as technical support for commercial manufacturing and new product introduction.
• Product risk management and quality risk management.
• Management of change.
• Design/ Author/ Review/ Approve/ Execute process development studies in support of new product introduction and ongoing manufacturing support.
• Provide technical input into quality notification by authoring/reviewing/approving investigations.
• Execution of equipment/qualification validation programs; including re-qualification and re-validation.
• Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
• Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
• Statistical data analysis to support development and commercialisation batches.
• Support continuous improvement through Lean Six Sigma methodologies.
• Leading and active participation in projects, system failure investigations and investigation reports.
• Execution/development of change controls.
• Contribution to Kaizen events as appropriate.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.
• Implement subsequent corrective action through the change management system.
• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
• Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
• Key process engineer in the commercial products engineering team to address and lead any management of changes, risks, impact assessments etc. associated with the commercial products.
• Role will report to Technical Engineering commercial support coach.

Qualifications & Experience:

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
• 3-5 years’ Engineering/Technical experience; ideally in manufacturing, preferably GMP Setting.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile filling processes and equipment.
• Proficiency in Microsoft Office and job related computer applications required.
• Data analysis experience required.
• Lean Six Sigma Methodology experience desired.

An exciting career opportunity awaits with a global medical devices company based in Cork for a Supplier Quality Engineer on a 12 months' contract.

Job Responsibilities of Supplier Quality Engineer:

• Providing engineering support for activities related to supplier selection and evaluation.
• Contributing to the development, maintenance and improvements of supplier quality policies and procedures.
• Reviewing and approving all material and component specification drawings.
• As a Supplier Quality Engineer you will be assessing supplier capabilities through direct visits, technical discussions and quality system audits.
• Contributing to and participating in Material Review Boards & supplier performance reviews.
• Evaluating and establishing Supplied Data Agreements with suppliers.
• Working with product line engineering to assess and address material quality issues.
• Demonstrating a thorough understanding of related quality standards, including ISO and GMP.
• As a Supplier Quality Engineer you will be assisting in establishing and implementing Supplier QA Department improvement goals.
• Evaluating in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Travel will be expected in this role.

Job Requirements:

• Bachelor’s Degree in relevant discipline (min Level 8)
• 2+ years experience in an Engineering / Quality role
• Excellent interpersonal and communication skills with good leadership abilities.
• Excellent analytical and problem solving skills.
• Knowledge of Quality System Requirements
• Proven track record of working in a fast paced environment with strong technical capabilities
• Capable of handling multiple development aspects of assigned projects

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

An exciting career opportunity awaits with a global medical devices company based in Cork for a Supplier Quality Engineer on a 12 months' contract.

Job Responsibilities of Supplier Quality Engineer:

• Providing engineering support for activities related to supplier selection and evaluation.
• Contributing to the development, maintenance and improvements of supplier quality policies and procedures.
• Reviewing and approving all material and component specification drawings.
• As a Supplier Quality Engineer you will be assessing supplier capabilities through direct visits, technical discussions and quality system audits.
• Contributing to and participating in Material Review Boards & supplier performance reviews.
• Evaluating and establishing Supplied Data Agreements with suppliers.
• Working with product line engineering to assess and address material quality issues.
• Demonstrating a thorough understanding of related quality standards, including ISO and GMP.
• As a Supplier Quality Engineer you will be assisting in establishing and implementing Supplier QA Department improvement goals.
• Evaluating in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Travel will be expected in this role.

Job Requirements:

• Bachelor’s Degree in relevant discipline (min Level 8)
• 2+ years experience in an Engineering / Quality role
• Excellent interpersonal and communication skills with good leadership abilities.
• Excellent analytical and problem solving skills.
• Knowledge of Quality System Requirements
• Proven track record of working in a fast paced environment with strong technical capabilities
• Capable of handling multiple development aspects of assigned projects

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

One of my favourite clients in Cork has just opened some really interesting 2 year contract roles in Manufacturing and Project Engineering. Driven by expansion they need a number of committed and ambitious Engineers to help them role out advanced in their manufacturing lines and processes.
If you have 5+ years in a Medical Device environment and experience of either the introduction of new Automated Manufacturing Lines or alternatively Product/Process Validations then give me a call on 087 3618142 or message me here for more.

About the Job:

• Initiate, co-ordinate and complete assigned projects within the engineering department within budget.
• Complete Process / Product / Equipment Validations in conjunction with Quality/Validation group.
• Conduct process feasibility trials / process DOE’s to determine appropriate/robust process windows.
• Prepare & execute OQ / PQ protocols for process / material changes as needed.
• Work in conjunction with the Quality & Validation group to determine appropriate validation sampling and acceptance criteria.
• Liaise with operations and technician group to prepare plan for validation builds.
• Co-ordinate the execution of OQ / PQ builds.
• Prepare OQ / PQ validation reports and deviations as required.
• Conduct process capability analysis using Minitab.
• Maintain and develop manufacturing process documentation and procedures. All process changes and modifications to be documented and tracked closely.
• Responsible for dealing with process, product and quality issues to achieve long term solutions.
• Lead and co-ordinate cost resolution projects year on year as per individual goals.
• Lead and co-ordinate Risk Mitigation initiatives such as FMEA and Risk Assessments.

Working Knowledge of the following would be an advantage but not a requirement;

• Automated / Semi Automated assembly equipment.
• Injection moulding and mould tools.
• High precision Punch & Die Sets.
• Heat sealing, ultrasonic welding, leak testing, vision systems.
• OEE Line performance methodology.
• Minitab/ Lean 6 Sigma techniques
• Root Cause Analysis methodology
• Microsoft Excel to an advanced level
• AutoCAD.

About You:

• Degree in Mechanical / Production Engineering or equivalent.
• Minimum of 3 years relevant experience, preferably within Medical Device industry or other regulated environments.
• Working knowledge of Product & Process validations essential.
• Excellent Engineering ability
• Strong organisational ability
• Self motivation and drive
• Demonstrate a high level of responsiveness to internal customers (eg. production)
• Communication- strong written, oral and presentational skills.

For more on the role call Nigel on 087 3618142 or send your CV for consideration.

An exciting career opportunity awaits with a global medical devices company based in Cork for a Supplier Quality Engineer on a 12 months' contract.

Job Responsibilities of Supplier Quality Engineer:

• Providing engineering support for activities related to supplier selection and evaluation.
• Contributing to the development, maintenance and improvements of supplier quality policies and procedures.
• Reviewing and approving all material and component specification drawings.
• As a Supplier Quality Engineer you will be assessing supplier capabilities through direct visits, technical discussions and quality system audits.
• Contributing to and participating in Material Review Boards & supplier performance reviews.
• Evaluating and establishing Supplied Data Agreements with suppliers.
• Working with product line engineering to assess and address material quality issues.
• Demonstrating a thorough understanding of related quality standards, including ISO and GMP.
• As a Supplier Quality Engineer you will be assisting in establishing and implementing Supplier QA Department improvement goals.
• Evaluating in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Travel will be expected in this role.

Job Requirements:

• Bachelor’s Degree in relevant discipline (min Level 8)
• 2+ years experience in an Engineering / Quality role
• Excellent interpersonal and communication skills with good leadership abilities.
• Excellent analytical and problem solving skills.
• Knowledge of Quality System Requirements
• Proven track record of working in a fast paced environment with strong technical capabilities
• Capable of handling multiple development aspects of assigned projects

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Summary:
Our client is a global biopharma company based in Carlow and is looking for a Process Engineer who will provide technical support for commercial manufacturing and new product introduction. The right candidate will perform product risk management and quality risk management and will Design/ Author/ Review/ Approve/ Execute process development studies in support of new product introduction and ongoing manufacturing support and qualification/validation documentation and studies in line with the standard approval process.

Responsibilities:

• Serve as technical support for commercial manufacturing and new product introduction.
• Product risk management and quality risk management.
• Management of change.
• Design/ Author/ Review/ Approve/ Execute process development studies in support of new product introduction and ongoing manufacturing support.
• Provide technical input into quality notification by authoring/reviewing/approving investigations.
• Execution of equipment/qualification validation programs; including re-qualification and re-validation.
• Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
• Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
• Statistical data analysis to support development and commercialisation batches.
• Support continuous improvement through Lean Six Sigma methodologies.
• Leading and active participation in projects, system failure investigations and investigation reports.
• Execution/development of change controls.
• Contribution to Kaizen events as appropriate.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.
• Implement subsequent corrective action through the change management system.
• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
• Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
• Key process engineer in the commercial products engineering team to address and lead any management of changes, risks, impact assessments etc. associated with the commercial products.
• Role will report to Technical Engineering commercial support coach.

Qualifications & Experience:

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
• 3-5 years’ Engineering/Technical experience; ideally in manufacturing, preferably GMP Setting.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile filling processes and equipment.
• Proficiency in Microsoft Office and job related computer applications required.
• Data analysis experience required.
• Lean Six Sigma Methodology experience desired.

An exciting career opportunity awaits with a global medical devices company based in Cork for a Supplier Quality Engineer on a 12 months' contract.

Job Responsibilities of Supplier Quality Engineer:

• Providing engineering support for activities related to supplier selection and evaluation.
• Contributing to the development, maintenance and improvements of supplier quality policies and procedures.
• Reviewing and approving all material and component specification drawings.
• As a Supplier Quality Engineer you will be assessing supplier capabilities through direct visits, technical discussions and quality system audits.
• Contributing to and participating in Material Review Boards & supplier performance reviews.
• Evaluating and establishing Supplied Data Agreements with suppliers.
• Working with product line engineering to assess and address material quality issues.
• Demonstrating a thorough understanding of related quality standards, including ISO and GMP.
• As a Supplier Quality Engineer you will be assisting in establishing and implementing Supplier QA Department improvement goals.
• Evaluating in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Travel will be expected in this role.

Job Requirements:

• Bachelor’s Degree in relevant discipline (min Level 8)
• 2+ years experience in an Engineering / Quality role
• Excellent interpersonal and communication skills with good leadership abilities.
• Excellent analytical and problem solving skills.
• Knowledge of Quality System Requirements
• Proven track record of working in a fast paced environment with strong technical capabilities
• Capable of handling multiple development aspects of assigned projects

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.